BIC-8: Positive Signs for Early-Rule Out of Suspected ACS Using Copeptin

AMSTERDAM, The Netherlands—In low-to-intermediate risk patients who present to the chest pain unit with suspected acute coronary syndromes (ACS) but are found to be troponin negative, management based on copeptin testing does not increase adverse events compared with standard care. Moreover, the strategy improves the odds of early discharge, researchers reported in a Hot Line session September 3, 2013, at the European Society of Cardiology Congress.

For the BIC-8 trial, researchers led by Martin Möckel, MD, PhD, of Charité University (Berlin, Germany), enrolled 902 patients who had suspected ACS but were troponin negative. All patients underwent copeptin testing and were randomized to 1 of 2 management strategies:

• Standard process: With the treating staff blinded to copeptin results, patients underwent serial cardiac troponin and ECG assessment then received further care according to current guidelines.
• Copeptin-guided process: Patients who were copeptin positive (≥ 10 pmol/L) received standard care. Copeptin-negative patients were discharged into ambulant care, and an outpatient visit was scheduled to take place within 72 hours.

Faster Discharge with No Increase in MACE

Approximately 80% of patients in each group were copeptin negative. Protocol deviations occurred at a rate of 7.3% in the standard group and 17.3% in the copeptin group, mostly involving patients admitted to the hospital despite negative results.

In the main intention-to-treat analysis, the copeptin-guided strategy met noninferiority criteria for 30-day MACE (margin of 5%) compared with standard care. The copeptin group fared even better in per protocol analysis (table 1).

Table 1. MACE at 30 Days

In addition, copeptin-positive patients had correspondingly higher rates of MACE compared with those with low biomarker measurements.

“Clinicians need to know whether this process really works,” Dr. Möckel said. “Clinicians also feel that they may miss an important diagnosis.” Speaking to these concerns, he reported that more patients were discharged directly from the emergency department with copeptin-guided care than with standard care (66% vs. 12%; P < 0.001). In the copeptin-guided arm, 14 biomarker-negative patients had an adverse event, amounting to a “miss rate” of 4.1%: 12 were kept in the hospital due to clinical symptoms and 2 were discharged before being rehospitalized for repeat revascularization.

Results Address Clinical Need

Although only 10% of patients presenting with chest pain are ultimately diagnosed with acute MI, the standard of care is to monitor and evaluate patients over 6 to 12 hours, Dr. Möckel said, adding, “On the other hand, EDs worldwide increasingly face overcrowding, which leads to worse outcomes.” Therefore, there is a clinical need for the ability to instantly rule out acute MI and enable early discharge. Observational studies have shown that, when used together, cardiac troponin and copeptin have a negative predictive value of 99%, he reported.

BIC-8 demonstrates that a “single combined troponin and copeptin test at presentation can aid a safe and early discharge process in low-to-intermediate risk patients presenting with suspected ACS,” Dr. Möckel concluded, noting that the strategy stands to change practice.

Discussant Bertil Lindahl, MD, PhD, Uppsala University Hospital (Uppsala, Sweden), noted that randomized studies comparing a new diagnostic strategy with the current standard are “unfortunately uncommon but precisely what is needed in the era of evidence-based medicine.”

Several alternative rule-out strategies also deserve evaluation in prospective trials, he said, including “a single high sensitivity cardiac troponin with a cutoff substantially bellow the 99th percentile level, 2 measurements of high sensitivity cardiac troponin 1 hour apart, and the combination and high-sensitivity cardiac troponin and a risk score.”

Dr. Lindahl agreed that “having a specific rule-out strategy in addition to a more conventional ‘rule-in’ strategy does have the possibility to change clinical practice.”

Study Details

MACE was defined as all-cause death or survived sudden cardiac arrest, acute MI, rehospitalization for ACS, acute unplanned PCI, CABG, or documented life-threatening arrhythmias.

 

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Source:
Möckel M. BIC-8: Instant early rule-out using cardiac troponin and copeptin in low-to intermediate-risk patients with suspected ACS: A prospective, randomized multicenter study. Presented at: European Society of Cardiology Congress; September 3, 2013; Amsterdam, The Netherlands.

 

 

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